Cleared Special

K102600 - SIMPLYGO BREAST PUMP

K102600 is an FDA 510(k) clearance for SIMPLYGO BREAST PUMP, manufactured by Evenflo Company, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 103-day FDA review.

K102600 · Evenflo Company, Inc. · Obstetrics & Gynecology device
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Dec 2010
Decision
103d
Days
Class 2
Risk

K102600 is an FDA 510(k) clearance for the SIMPLYGO BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Company, Inc. (Miamisburg, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102600

510(k) Number K102600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date December 22, 2010
Days to Decision 103 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 161d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K102600.
FREEMIE (R)
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K101157 · Mapa GmbH · Sep 2010
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K093145 · Uzinmedicare Co. · Aug 2010
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
K093648 · Simplisse, Inc. · Jul 2010
K102600 · SIMPLYGO BREAST PUMP
Download PDF Evenflo Company, Inc.